MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-03 for AIA-360 019945 manufactured by Tosoh Bioscience, Inc..
[133827520]
(b)(4). Device evaluation by manufacturer: a field service engineer (fse) was at customer's site to resolve the reported issue. Fse confirmed complaint from instrument calibration printout. Fse noted the substrate dispense stream appeared weak. Fse replaced the substrate solenoid valve and cleaned the substrate lines with canned air. The customer completed calibration run successfully without errors. No further action required by field service. The aia-360 instrument is functioning as expected. A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4). There were no similar complaints identified during the search period. The aia-360 operator's manual under chapter 7 - error messages and flags, [0014] calibration data zigzag is an operating error generated when the calibration curve rates are not in ascending order. The solution is for the customer to repeat the calibration. The most probable cause of the reported event was due to faulty substrate solenoid valve.
Patient Sequence No: 1, Text Type: N, H10
[133827521]
A customer reported getting error 0014 "calibration data zig zag" during calibration on the aia-360 instrument. The customer stated that it was due to calibrators being out of order. A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for luteinizing hormone (lh ii). There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005529799-2018-05411 |
| MDR Report Key | 8215302 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-03 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-10-03 |
| Report Date | 2019-01-03 |
| Date Reported to FDA | 2019-01-03 |
| Date Reported to Mfgr | 2019-01-03 |
| Date Mfgr Received | 2018-10-03 |
| Device Manufacturer Date | 2016-05-19 |
| Date Added to Maude | 2019-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DORIA ESQUIVEL |
| Manufacturer Street | 6000 SHORELINE COURT SUITE 101 |
| Manufacturer City | SOUTH SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 6509368123 |
| Manufacturer G1 | TOSOH BIOSCIENCE, INC. (MANUFACTURER) |
| Manufacturer Street | 3600 GANTZ ROAD |
| Manufacturer City | GROVE CITY OH 43123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIA-360 |
| Generic Name | AIA-360 |
| Product Code | KHO |
| Date Received | 2019-01-03 |
| Model Number | AIA-360 |
| Catalog Number | 019945 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH BIOSCIENCE, INC. |
| Manufacturer Address | 3600 GANTZ ROAD GROVE CITY OH 43123 US 43123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-03 |